Method for filling pharmaceutical containers
a technology for filling and sealing pharmaceutical containers, applied in the direction of liquid materials, transportation and packaging, packaging goods types, etc., can solve the problems of drug safety hazards in occupational exposure, human microbial contamination, and difficult production of sterile pharmaceuticals by humans
Active Publication Date: 2019-05-09
VANRX PHARMASYST
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- Application Information
AI Technical Summary
Benefits of technology
This approach allows for efficient, aseptic filling and sealing of pharmaceutical containers while maintaining a high degree of cleanliness and safety, reducing the risk of contamination and occupational exposure, and enabling simultaneous processing of multiple containers.
Problems solved by technology
By its very nature, the production of sterile pharmaceuticals by humans can be problematic.
Humans can be a large source of microbial contamination.
Also, with increased potencies, some drugs can be hazardous in occupational exposure.
A significant portion of all filling equipment is of such complexity that it cannot be integrated in a controlled environment enclosure.
Such filling equipment can only be installed in a restricted access barrier system; which environment is much less secure than complete physical barrier provided by a controlled environment enclosure such as an isolator.
The other negative aspect of complex equipment is cleanability, which can be a concern for multi-product use and in particular for highly potent products.
In particular, systems employing conveyor belts to convey nested containers are known, and these present considerable challenges as regards cleaning to a degree acceptable in the pharmaceutical industry.
The handling and singulation of elastomeric stoppers and aluminum crimp caps is known to be problematic at times. Blockages of vibratory chutes cannot be prevented at all times and require operator interventions from time to time to free blockages.
Most prior art vial filling machine designs deviate from this rule, because of perceived difficulties in placing of stoppers and caps when containers are located in a nest.
However, is practically impossible to transfer the stopper bowl and chutes aseptically from the sterilizing autoclave to the processing environment.
The particular example is limited in practical applications for at least three reasons.
The packing density of 60-120 containers with a foot print of 8″×9″ in a nest does not allow for a matching cap nest design as shown in US 20120248057 A1, because its holding features take up too much space.
Secondly the closure has to be held by the nest in such a way that the force required for capping of the vial is directed without a resulting force vector acting on the tamper evident feature.
In summary, while the use of nested containers has been established in industry, challenges remain as to how to manage such containers within a controlled environment while ensuring that the equipment used in the process is cleanable to a degree acceptable in the pharmaceutical industry, an industry in which regulations are exceptionally stringent.
Method used
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[0036]A method and associated system for filling pharmaceutical containers is described at the hand of the schematic depiction in FIG. 1, as well as FIG. 2 and FIG. 3. A filling system 10 for filling pharmaceutical containers 90 with a pharmaceutical product is disposed within a controlled environment enclosure 20. Controlled environment enclosure 20 is configured for maintaining an aseptic condition. In some embodiments, in particular that shown in FIG. 1, the pharmaceutical product may be a liquid product. In other embodiments, the product may be a solid pharmaceutical product. The pharmaceutical product may potentially be toxic or otherwise harmful. As will be described in more detail below, the filling system 10 can be configured to locate, target, and fill containers 90 held in a container nest 70 within a container tub 80 (see FIG. 2). Many types of containers 90 are contemplated herein, including, but not limited to vials, syringes, bottles, and ampoules.
[0037]Pharmaceutical ...
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In one general aspect, a method for filling multiple containers with a pharmaceutical product is disclosed, which comprises decontaminating sealed nested materials in a transfer chamber, removing from the sealed nested materials one or both of a container nest holding the multiple containers and a closure nest holding multiple closures, transferring from the transfer chamber to a controlled environment enclosure the removed nest, aseptically filling the containers with the pharmaceutical product, and closing the containers with the multiple closures. The nests are configured to allow multiple closures and containers to be simultaneously aligned concentrically, and closed simultaneously. Spring-loaded retaining structures on the closure nest allow it to releasably retain multiple closures above the corresponding multiple containers. In some embodiments the spring-loaded features are monolithically integrated with the closure nest. The product may be lyophilized in partially sealed containers while the sealing closures are releasably retained by the closure nest.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This is a continuation of U.S. application Ser. No. 15 / 719,736, filed Sep. 29, 2017; which is Divisional of U.S. patent application Ser. No. 14 / 912,145, filed Feb. 15, 2016; which is a National Stage Entry of PCT Patent Application Number PCT / US2014 / 051223, filed Aug. 15, 2014; which claims benefit under 35 U.S.C. § 119(e) of U.S. Patent Provisional Application Ser. No. 61 / 867,014, filed Aug. 16, 2013, the disclosures of which are incorporated by reference herein.BACKGROUND OF THE INVENTIONField of the Invention[0002]The present invention relates to a device, system and method for filling and sealing of pharmaceutical containers. In particular, it relates to a device, system and method for filling and sealing of pharmaceutical containers within a controlled environment chamber.Description of the Related Art[0003]By its very nature, the production of sterile pharmaceuticals by humans can be problematic. Humans can be a large source of micr...
Claims
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IPC IPC(8): B65B7/16B65B7/28B65D51/00B65D1/02B65B3/00B65B55/08B65B55/04B65B63/08B65B55/10B65B55/02
CPCB65B7/161B65B7/28B65D51/002B65D1/0246B65B7/2821B65B3/003B65B55/08B65B55/04B65D51/00B65B63/08B65B55/10B65B55/027B65D41/28
InventorBROADBENT, NICKIMMERZEEL, JEROENPROCYSHYN, CHRISTOPHERGOLD, ROSS M.PARK, STEVE SANG JOON
OwnerVANRX PHARMASYST